Back in 1984, the extrapolated statistics from relatively few records in only several states of the United States estimated that between 44,000-98,000 people annually die in hospitals because of medical errors.[2] Much work has been done since then, including work by the author of that study who moved on from those low estimates back in the 1990s. For example, the Centers for Disease Control and Prevention currently says that 75,000 patients die annually, in hospitals alone, from infections alone - just one cause of harm in just one kind of care setting.[3] From all causes there have been numerous other studies, including "A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care" by John T. James, PhD[4] that estimates 400,000 unnecessary deaths annually in hospitals alone. Less than one quarter of care takes place in hospitals. Across all care settings the numbers are higher.

Another study notes that about 1.14 million patient-safety incidents occurred among the 37 million hospitalizations in the Medicare population over the years 2000-2002. Hospital costs associated with such medical errors were estimated at $324 million in October 2008 alone.[5]

Between 15,000 and 19,000 malpractice suits are brought against doctors each year.[6]

The plaintiff is/ was the patient, or a legally designated party acting on behalf of the patient, or – in the case of a wrongful-death suit – the executor or administrator of a deceased patient's estate.

The defendant is the health care provider. Although a 'health care provider' usually refers to a physician, the term includes any medical care provider, including dentists, nurses, and therapists. As illustrated in Columbia Medical Center of Las Colinas v Bush, 122 S.W. 3d 835 (Tex. 2003), "following orders" may not protect nurses and other non-physicians from liability when committing negligent acts. Relying on vicarious liability or direct corporate negligence, which was found in the case of Dany Decell, CEO, claims may also be brought against hospitals, clinics, managed care organizations or medical corporations for the mistakes of their employees.

A plaintiff must establish all five elements of the tort of negligence for a successful medical malpractice claim.[7]

A duty was owed: a legal duty exists whenever a hospital or health care provider undertakes care or treatment of a patient.

A duty was breached: the provider failed to conform to the relevant standard care.

The breach caused an injury: The breach of duty was a direct cause and the proximate cause of the injury.

Deviation from the accepted standard: It must be shown that the practitioner was acting in a manner which was contrary to the generally accepted standard in his/her profession.

Damage: Without damage (losses which may be pecuniary or emotional), there is no basis for a claim, regardless of whether the medical provider was negligent. Likewise, damage can occur without negligence, for example, when someone dies from a fatal disease.

Like all other tort cases, the plaintiff or their attorney files a lawsuit in a court with appropriate jurisdiction. Between the filing of suit and the trial, the parties are required to share information through discovery. Such information includes interrogatories, requests for documents and deposition. If both parties agree, the case may be settled pre-trial on negotiated terms. If the parties cannot agree, the case will proceed to trial.

The plaintiff has the burden of proof to prove all the elements by a preponderance of evidence. At trial, both parties will usually present experts to testify as to the standard of care required, and other technical issues. The fact-finder (judge or jury) must then weigh all the evidence and determine which side is the most credible.

The fact-finder will render a verdict for the prevailing party. If the plaintiff prevails, the fact-finder will assess damages within the parameters of the judge's instructions. The verdict is then reduced to the judgment of the court. The losing party may move for a new trial. In a few jurisdictions, a plaintiff who is dissatisfied by a small judgment may move for additur. In most jurisdictions, a defendant who is dissatisfied with a large judgment may move for remittitur. Either side may take an appeal from the judgment.

Expert witnesses must be qualified by the Court, based on the prospective experts qualifications and the standards set from legal precedent. To be qualified as an expert in a medical malpractice case, a person must have a sufficient knowledge, education, training, or experience regarding the specific issue before the court to qualify the expert to give a reliable opinion on a relevant issue.[8] The qualifications of the expert are not the deciding factors as to whether the individual will be qualified, although they are certainly important considerations. Expert testimony is not qualified "just because somebody with a diploma says it is so" (United States v. Ingham, 42 M.J. 218, 226 [A.C.M.R. 1995]). In addition to appropriate qualifications of the expert, the proposed testimony must meet certain criteria for reliability. In the United States, two models for evaluating the proposed testimony are used:

The more common (and some believe more reliable) approach used by all federal courts and most state courts is the 'gatekeeper' model, which is a test formulated from the US Supreme Court cases Daubert v. Merrell Dow Pharmaceuticals (509 U.S. 579 [1993]), General Electric Co. v. Joiner (522 U.S. 136 [1997]), and Kumho Tire Co. v. Carmichael (526 U.S. 137 [1999]). Before the trial, a Daubert hearing[9] will take place before the judge (without the jury). The trial court judge must consider evidence presented to determine whether an expert's "testimony rests on a reliable foundation and is relevant to the task at hand." (Daubert, 509 U.S. at 597). The Daubert hearing considers 4 questions about the testimony the prospective expert proposes:

Whether a "theory or technique . . . can be (and has been) tested"

Whether it "has been subjected to peer review and publication".

Whether, in respect to a particular technique, there is a high "known or potential rate of error"

Whether there are "standards controlling the technique's operation".

Some state courts still use the Frye test that relies on scientific consensus to assess the admissibility of novel scientific evidence. Daubert expressly rejected the earlier federal rule's incorporation of the Frye test. (Daubert, 509 U.S. at 593-594) Expert testimony that would have passed the Frye test is now excluded under the more stringent requirements of Federal Rules of Evidence as construed by Daubert.

In view of Daubert and Kuhmo, the pre trial preparation of expert witnesses is critical.[10] A problem with Daubert is that the presiding judge may admit testimony which derives from highly contested data. The judge may expand the limits contained in the "school of thought" precedent. Papers that are self-published may be admiited as the basis for expert testimony. Non-peer reviewed journals may also be admitted in similar fashion. The only criterion is the opinion of a single judge who, in all likelihood, has no relevant scientific or medical training.[11]

Many states also require that a certificate of merit before a malpractice lawsuit be filed which requires a report from a medical physician that the physician accused of negligence breached the standard of care and caused injury to the patient.

The plaintiff's damages may include compensatory and punitive damages.[12] Compensatory damages are both economic and non-economic. Economic damages include financial losses such as lost wages (sometimes called lost earning capacity), medical expenses and life care expenses.[13] These damages may be assessed for past and future losses. Non-economic damages are assessed for the injury itself: physical and psychological harm, such as loss of vision, loss of a limb or organ, the reduced enjoyment of life due to a disability or loss of a loved one, severe pain and emotional distress. Punitive damages are only awarded in the event of wanton and reckless conduct.

In one particular circumstance physicians, particularly psychiatrists, are held to a different standard than other defendants in a tort claim. Suicide is legally viewed as an act which terminates a chain of causality. Although the defendant may be held negligent for another's suicide, he or she is not responsible for damages which occur after the act. An exception is made for physicians. Although there exists no protocol or algorithm for predicting suicidality with any level of certainty, courts throughout the United States have found physicians to be negligent. Furthermore, damages are routinely assessed based on losses which would hypothetically accrue after the act of suicide.[14]

There is only a limited time during which a medical malpractice lawsuit can be filed. These time limits are set by statute in a common law. In civil law systems, similar provisions are usually part of the civil code or criminal code and are often known collectively as "periods of prescription" or "prescriptive periods." The length of the time period and when that period begins vary per jurisdiction and type of malpractice. Therefore each state has different time limits set.

A 2011 study in the New England Journal of Medicine reported that 75% of physicians in "low-risk" specialties and virtually 100% of physicians in "high-risk" specialties could expect to face a malpractice claim during their careers. However, the authors also noted that the vast majority of malpractice claims did not lead to any indemnity payments.[15]

Most (73%) settled malpractice claims involve medical error. A 2006 study concluded that claims without evidence of error "are not uncommon, but most [72%] are denied compensation. The vast majority of expenditures [54%] go toward litigation over errors and payment of them. The overhead costs of malpractice litigation are exorbitant." Physicians examined the records of 1452 closed malpractice claims. Ninety-seven percent were associated with injury; of them, 73% got compensation. Three percent of the claims were not associated with injuries; of them, 16% got compensation. 63% were associated with errors; of them, 73% got compensation (average $521,560). Thirty-seven percent were not associated with errors; of them, 28% got compensation (average $313,205). Claims not associated with errors accounted for 13 to 16% percent of the total costs. For every dollar spent on compensation, 54 cents went to administrative expenses (including lawyers, experts, and courts). Claims involving errors accounted for 78 percent of administrative costs.[16][17]

A 2004 study of medical malpractice claims in the United States examining primary care malpractice found that though incidence of negligence in hospitals produced a greater proportion of severe outcomes, the total number of errors and deaths due to errors were greater for outpatient settings. No single medical condition was associated with more than five percent of all negligence claims, and one-third of all claims were the result of misdiagnosis.[18]

Doctors' groups, patients, and insurance companies have criticized medical malpractice litigation as expensive, adversarial, unpredictable, and inefficient. They claim that the cost of medical malpractice litigation in the United States has steadily increased at almost 12 percent annually since 1975.[19] More recent research from the same source has found that tort costs as a percentage of GDP dropped between 2001 and 2009, and are now at their lowest level since 1984.[20] Jury Verdict Research, a database of plaintiff and defense verdicts, says awards in medical liability cases increased 43 percent in 1999, from $700,000 to $1,000,000. However, more recent research from the U.S. Department of Justice has found that median medical malpractice awards in states range from $109,000 to $195,000.[21]

These critics assert that these rate increases are causing doctors to go out of business or move to states with more favorable tort systems.[22] Not everyone agrees, though, that medical malpractice lawsuits are solely causing these rate increases.[23] A 2003 report from the General Accounting Office found multiple reasons for these rate increases, with medical malpractice lawsuits being the primary driver.[24] Despite noting multiple reasons for rate increases, the report goes on to state that the "GAO found that losses on medical malpractice claims-which make up the largest part of insurers’ costs-appear to be the primary driver of rate increases in the long run." More recent data has indicated that medical malpractice rates are generally no longer rising. In 2011, data pooled from the industry by the publication Medical Liability Monitor indicated that medical malpractice insurance rates had declined for four straight years. The decrease was seen in both states that had enacted tort reform and in states that had not, leading actuaries familiar with the data to suggest that patient safety and risk management campaigns had had a more significant effect.[25]

The majority of the American public supports reforms to the malpractice system. However, surveys show that the majority of the American public also vastly underestimate the extent of medical errors.[26] Recent research has shown that while both health consumers and health producers are concerned about some of the adverse consequences of healthcare litigation, health consumers perceive that increased healthcare litigation can reduce the incentives for negligence on the part of healthcare providers.[27]

At the same time, studies of these claims have found[28][29][30][31] that there is no problem of increasing malpractice verdicts and insurance costs driving doctors out of business.

The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject. Please improve this article and discuss the issue on the talk page.(March 2012)

Proponents of medical liability reform argue that medical malpractice lawsuits restrict patient access to health care by driving physicians out of business or encouraging them to limit high-risk procedures. One in 12 obstetricians who have reported changes in their practice as a result of the risk or fear of professional liability claims have stopped delivering babies.[32]

Medical Liability reform took place in Texas in 2003. Many physicians said they moved to Texas as a result. According to the Texas Medical Board, "Medical license applications jumped 58% from 2,561 in 2003 to 4,041, an unprecedented number, according to the Texas Medical Board. The state saw a 7.2% growth in the number of ob-gyns between May 2003 and May 2008. Similar increases were observed in other specialties." According to the Texas Insurance Department, physicians in Texas have seen a 25% overall drop in medical liability insurance rates since 2003.[33]

Physician advocacy groups say 60% of liability claims against doctors are dropped, withdrawn, or dismissed without payment. However even those cases have a price, costing an average of more than $22,000 to defend in 2008 ($18,000 in 2007). Physicians are found not negligent in over 90% of cases that go to trial - yet more than $110,000 (2008 estimate, $100,000 in 2007) per case is spent defending those claims.[32]

Malpractice has both direct and indirect costs, including "defensive medicine." According to the American Medical Association, defensive medicine increases health systems costs by between $84 and $151 billion each year. Studies place the direct and indirect costs of malpractice between 5% and 10% of total U.S. medical costs, as described below:[34]

About 10 percent of the cost of medical services is linked to malpractice lawsuits and more intensive diagnostic testing due to defensive medicine, according to a January 2006 report prepared by PricewaterhouseCoopers LLP for the insurers’ group America’s Health Insurance Plans. The figures were taken from a March 2003 study by the U.S. Department of Health and Human Services that estimated the direct cost of medical malpractice was 2 percent of the nation’s health-care spending and said defensive medical practices accounted for 5 percent to 9 percent of the overall expense.

In one study of defensive medicine, Daniel P. Kessler and Mark McClellan found that, in treatment of heart disease, malpractice reforms reduced costs by 5% to 9% without affecting deaths or complications.[35]

Other estimates conclude that the cost of the medical liability system, including defensive medicine, is up to 3%.[36][37] Uwe E. Reinhard wrote that many analyses of the costs of the malpractice system don't consider the benefits, such as compensating injured patients and motivating improvements. Proposed reforms would only reduce national health spending by 0.5%, according to the Congressional Budget Office.[38] It should also be noted that litigation driven defensive medicine results - by definition - in doctors ordering medical care that they believe will hurt a patient because they want insulation from a potential malpractice lawsuit for which the vast majority of doctors have medical insurance. Some argue that these studies are written by those with a bias towards tort reform, are simply inaccurate, and underestimate the extent to which doctors put their patients' interests above their own potential fears of litigation.

Many supporters of medical liability reform believe that laws modeled after California's Medical Injury Compensation Reform Act (MICRA) should be passed at the federal level. "California is the perfect model for federal medical malpractice reform", said Lisa Maas, executive director of Californians Allied for Patient Protection. "MICRA is considered the gold standard in terms of what other states look to in tort reform in the medical liability area."[39]

MICRA was passed in the midst of a liability insurance crisis in 1975, as premiums soared and some California physicians were unable to find liability coverage. The law limits non-economic damages in medical malpractice cases to $250,000. It also imposes a sliding scale on plaintiffs' attorney fees that prohibits them from charging more than 40% on any recovery.[40]

MICRA advocates say the law has stabilized liability costs and preserved access to thousands of physicians, nurses, hospitals and other healthcare providers. In particular, MICRA is said to protect specialty and high-risk services, including women's services, community clinics and rural providers that can least afford skyrocketing insurance costs. In addition, supporters say MICRA has saved healthcare consumers tens of billions of dollars by protecting against runaway damage awards.[41] Consumer advocates contend that MICRA had little effect, and that doctors did not see any rate relief until insurance reform was passed with Proposition 103, which ordered a rate rollback and enacted strict regulation on insurance companies.[42]

The American Medical Association is leading a campaign to pass medical liability reform and protect patient access to health care. AMA Leaders are working with state medical associations to enact and defend strong tort reform laws. They continue to advocate for federal reforms based on solutions such as the MICRA laws.

The traditional approach to liability reform is to limit the amount of damages that can be recovered by a plaintiff (as noted above). Several new approaches to addressing medical malpractice have been investigated.[1]

Communication and Resolution Programs: When a medical error is identified, the patient is approached by the physician and/or health care system and they mutually arrive at a settlement. Several laws have been passed to facilitate communication and resolution (Mandatory presuit notification laws, apology laws and State-facilitated dispute resolution laws).

Safe Harbors for Adherence to Practice Guidelines: This approach provides a defense for physicians if they follow pre approved clinical practice guidelines.

Judge-directed compensation: A group of judges with expertise in medical malpractice meet with each sides attorneys and negotiates a settlement between the parties.

Administrative Compensation:Sweden and New Zealand created health courts. Claims are sent to these courts that have the authority to settle a claim. Attorneys are not required and the claims are settled based the opinions of neutral experts. Compensation is awarded based on preset schedules and are based on the degree of injury.

Many jurisdictions placed non-economic damages caps that limit the amount that victims of medical malpractice[43] can recover from negligent physicians, purportedly in an effort to decrease hospital and physician costs. However, it is possible these caps are merely to protect the interests of medical malpractice insurers given the extensive lobbying efforts of the United States Chamber of Commerce in promoting tort reform.[44]

In California, for example, recovery for non-economic damages are limited to $250,000. According to the Supreme Court of California, "noneconomic damages compensate the plaintiff for 'pain, suffering, inconvenience, physical impairment, disfigurement and other nonpecuniary damage [as per Cal.Civ.Code section 3333.2, subdivision (a)].' Section 1431.2, subdivision (b)(2) similarly defines noneconomic damages as 'subjective, non-monetary losses including, but not limited to, pain, suffering, inconvenience, mental suffering, emotional distress, loss of society and companionship, loss of consortium, injury to reputation and humiliation.'”[45]Tort reform supporters argue that states have enacted such laws in order to keep health care costs low, in addition to helping curb medical malpractice litigation. However, according to the Supreme Court of California, the state's non-economic damages caps are "not a legislative attempt to estimate the true damages suffered by plaintiffs, but rather an attempt to control and reduce medical malpractice insurance costs by placing a predictable, uniform limit on the defendant's liability for noneconomic damages."[46] This suggests that these limits were placed in order to protect medical malpractice insurers, rather than keeping healthcare costs low.

^Tom Baker, The Medical Malpractice Myth. University of Chicago Press, 2005. 222 pages. Page 3, "First, we know from the California study, as confirmed by more recent, better publicized studies, that the real problem is too much medical malpractice, not too much litigation."

^William M. Sage, M.D., Margaret Thompson, Cynthia Gorman, Melissa King. [ The Jury's Still Out: A Critical Look at Malpractice Reform], Center for American Progress, June 12, 2008. From the study, "There is no nationwide crisis [...] Malpractice is wrongly blamed for rising health care costs in the United States...Experts have found little correlation between malpractice claim increases and malpractice premium increases. "

^Most Mass. doctors face lower cost for malpractice coverage. From the article describing the study, "Despite assertions that high malpractice rates are driving them out of the state, Massachusetts doctors are paying less than they were in 1990, after adjusting for inflation, according to a Suffolk University Law School study."